Assistive Device for Hand Osteoarthritis

NCT ID: NCT02667145

Last Updated: 2016-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-01-31

Brief Summary

Randomized clinical trial , blind for evaluators, to assess the effectiveness of a self-care program using assistive technology for treatment of hand osteoarthritis.

Detailed Description

This program aims to:

• Encourage the use of assistive devices on a daily basis as the main form of joint protection.
• Encourage individual motivation, from the group in attendance, behavior change, developing the capacity of self-management of individuals of their health problems.

Will be held for 4 meetings with an average duration of 90 minutes. Meeting 1: Its proposal address the importance of self-care in the treatment of chronic diseases; knowing the OA of the hands and their main characteristics; recognize the importance of hand function for carrying out activities; understand the meaning of self-care and joint protection; motivation adherence to the program and behavior change.

Meeting 2: Present assistive devices as a protection feature; teach joint protection techniques and energy conservation focusing on the assistive device; deliver and demonstrate the use of assistive devices.

Meeting 3:Encouraging the adhesion of the techniques presented; making workshop for daily activities; verify the difficulties with devices use by the volunteers.

Meeting 4: Strengthening guidance given in previous meetings; make closing with the group to in connection with the program; motivated to continue carrying out the activities at home.

Conditions

Hand Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention

Self care program focusing on the assistive device, For 4 weeks (1 to week lasting 90 minutes).

Group Type: EXPERIMENTAL

Self care program focusing on the assistive device

Intervention Type: OTHER

self-heed program focusing on the assistive device will consist of four weekly meetings lasting approximately 90 minutes. it will be stimulated the self-heed through knowledge of pathology and guidelines of protection articulate, and will be supplied, and trained the use of assistive devices to improve the performance of volunteers in their daily activities. Assistive devices are devices, not attached to the body, which help people with limited movements and restrictions on participation in the activities of everyday life. Example: thickening of tableware, tin openers. These volunteers will be evaluated in three stages: 1-initial assessment 2-after completion of the program and 90 days after the initial assessment. The questionnaires that will be used are: EVA; SACRAH; COPM; WHOQOL-Bref.

Control group

receive only a brochure with orientations of joint protection.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Self care program focusing on the assistive device

self-heed program focusing on the assistive device will consist of four weekly meetings lasting approximately 90 minutes. it will be stimulated the self-heed through knowledge of pathology and guidelines of protection articulate, and will be supplied, and trained the use of assistive devices to improve the performance of volunteers in their daily activities. Assistive devices are devices, not attached to the body, which help people with limited movements and restrictions on participation in the activities of everyday life. Example: thickening of tableware, tin openers. These volunteers will be evaluated in three stages: 1-initial assessment 2-after completion of the program and 90 days after the initial assessment. The questionnaires that will be used are: EVA; SACRAH; COPM; WHOQOL-Bref.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Hand OA diagnosis according to the criteria of the American College of Rheumatology (ACR )
• Be properly registered in the rheumatology clinic of Hospital das Clínicas

Exclusion Criteria

• Surgical treatment or infiltration in the hands, in the last 6 months;
• Treatment of occupational therapy and / or physical therapy, or use of any TA feature (assist device or stent) in the last 6 months;
• Diagnosis of another rheumatologic disease or musculoskeletal system that compromise the hands associated.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daniela Salgado Amaral

OTHER

Sponsor Role: lead

Responsible Party

Daniela Salgado Amaral

Terapeuta Ocupacional

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Claudia DL Marques, PhD

Role: STUDY_CHAIR

Universidade Federal de Pernambuco

Locations

Hospital das Clínicas - Universidade Federal de Pernambuco

Recife, Pernambuco, Brazil

Countries

Brazil

References

Amaral DS, Duarte ALBP, Barros SS, Cavalcanti SV, Ranzolin A, Leite VMM, Dantas AT, Oliveira ASCRC, Santos PS, Silva JCA, Marques CDL. Assistive devices: an effective strategy in non-pharmacological treatment for hand osteoarthritis-randomized clinical trial. Rheumatol Int. 2018 Mar;38(3):343-351. doi: 10.1007/s00296-017-3892-1. Epub 2017 Nov 28.

Reference Type: DERIVED

PMID: 29185087 (View on PubMed)

Other Identifiers

UFPernambuco2015

Identifier Type: -

Identifier Source: org_study_id